Posted by Michael Jay on Wed, Mar 23, 2011
As Director of Business Development for Rx Trials, I am responsible for acquiring new study opportunities for all of our sites and for ensuring that each site has enough appropriate trials to sustain their operation. In the past several months, my curiosity has been peaked, about the concept of study brokers. In speaking with many sites I have learned many sites have actually used study brokers in an attempt to increase their study opportunity, however, I’m also not hearing that the results have matched the promise.
To start, what is a study broker?
A Study Broker typically acts as a middle- man between a Sponsors/CRO and Investigative Sites. Study brokers are characteristically targeting both sides of the fence. They are targeting Sponsors/CROs in an attempt to bring them faster access to Principal Investigators, often time newer Investigators Sponsors and CROs may not be aware of. Study brokers also are targeting sites, with the promise of bringing in new and potentially profitable study opportunities.
The Study Broker typically gets paid from the Investigative Site when a study is actually placed at a site. Some charge a flat fee based upon the contract regardless of the how the site performs, others share the risk and receive a percent of whatever the final amount is the site is paid. Brokers are typically not paid by the Sponsor or CRO, but there are some models that are. Some study brokers have non – competes with the sites where they place studies and some do not.
How are Study Brokers different from the SMO, TMO, or ISN models? The Study Broker claims that they are very different from these models. Brokers usually do not get involved with regulatory, contract processes or site management. Their main function is to match the Sponsor/CRO with a qualified Investigator to perform a specific trial, and then move on from that trial. They may or may not have any contractual relationship with the site beyond that study, however, some do. Their investments lie in the relationships necessary to make this match. Brokers historically do not “represent” the sites involved, nor do they represent the Sponsors/CROs. Their mission is task oriented.
Sponsors and CROs seem to love/hate study brokers. How about the sites? What has been the experience for them? That is the question I would love to hear from you on.